510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1339 of 3531

510(k) clearances, page 1339 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050241	Aos Humeral Nail	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2005-03-14
K050108	Sureflex and Accuflex Laser Lithotripsy Fibers	Innovaquartz LLC	GEX	Class II	2005-03-14
K050042	Wu's 4-Wheeled Neo Scooter, Wt-Xl4	Wu's Tech Co., Ltd.	INI	Class II	2005-03-14
K043570	Unicondylar Knee Repair System / Conformis Ucd	ConforMIS, Inc.	HSX	Class II	2005-03-14
K043511	Soleus Powered Wheelchair, Model Fad-2	Soleus Champ International Co., Ltd.	ITI	Class II	2005-03-14
K043144	Gen-Probe Aptima Assay for Neisseria Gonorrhoeae	Hologic, Inc.	LSL	Class II	2005-03-14
K043058	Pinnacle Constrained Acetabular Liners	Depuy, Inc.	KWZ	Class II	2005-03-14
K042711	Model Bmls03-7	BioMedical Life Systems Inc.	GZJ	Class II	2005-03-14
K042515	Smith & Nephew, Inc. High Performance Knee	Smith & Nephew, Inc.	JWH	Class II	2005-03-14
K042169	Stanbio Laboratory Sirrus Clinical Chemistry Analyzer	Stanbio Laboratory	JJE	Class I	2005-03-14
K041781	Ventilair II Medical Air Compressor	Hamilton Medical AG	BTI	Class II	2005-03-14
K050489	Innova 2100	GE Healthcare	OWB	Class II	2005-03-11
K050472	Lysus Infusion System	Ekos Corp.	DRA	Class II	2005-03-11
K050232	Rigiflex Single-Use Achalasia Balloon Dilator	Boston Scientific Corporation	PID	Class II	2005-03-11
K050215	Nitrile Powdered Examination Gloves (White)	Hartalega Sdn Bhd	LZA	Class I	2005-03-11
K050050	On Call Multi-Drug Home Test	Acon Laboratories, Inc.	LDJ	Class II	2005-03-11
K043565	Modification to Dynesys Spinal System	Zimmer Spine, Inc.	NQP	Class II	2005-03-11
K043303	Online Dat Propoxyphene Plus	Roche Diagnostics GmbH	JXN	Class II	2005-03-11
K043261	Harvest Graft Delivery Syringe	Terumo BCT, Ltd	FMF	Class II	2005-03-11
K042956	Vision	Varian Medical Systems, Inc.	IYE	Class II	2005-03-11
K042893	Under Buttocks Drape	Intl. Medsurg Connection, Inc.	KKX	Class II	2005-03-11
K042696	Bodyguard Infusion Pump System	Caesarea Medical Electronics, Ltd.	FRN	Class II	2005-03-11
K042556	Shineball PVC Manual Resusciator, ENT-1001, ENT-1003, ENT-1005, Shineball Silicone Manual Resusciator, ENT-1022,	Enter Medical Corporation	BTM	Class II	2005-03-11
K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	JWH	Class II	2005-03-11
K050458	Tsx-201A Aquilion Lb CT Scanner	Toshiba America Medical Systems, In.C	JAK	Class II	2005-03-10
K050278	Hemosil D-Dimer	Instrumentation Laboratory Co.	DAP	Class II	2005-03-10
K043541	Endolink True Movement System	Novare Surgical Systems, Inc.	GCJ	Class II	2005-03-10
K043526	Silverseal Tubular Wound Dressing with X-Static	Noble Fiber Technologies, Inc.	LGF	Class I	2005-03-10
K042981	Hyperq System	Biological Signal Processing, Ltd.	MWI	Class II	2005-03-10
K042952	Vinyl Exam Glove, Powder-Free, Non-Sterile	Zibo Hengchang Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2005-03-10
K042951	Pre-Powdered Vinyl Exam Gloves	Zibo Hengchang Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2005-03-10
K042319	Reliant Laser II System and Accessories	Reliant Technologies, Inc.	GEX	Class II	2005-03-10
K040751	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2005-03-10
K050452	Aurora Sr and Sra Applicator	Syneron Medical, Ltd.	GEX	Class II	2005-03-09
K050364	Malis 2000 Bipolar Electrosurgical System	Valley Forge Scientific Corp.	GEI	Class II	2005-03-09
K050355	Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150	Tissue Science Laboratories, PLC	PAI	Class III	2005-03-09
K050337	Sis Fistula Plug	Cook Biotech, Inc.	FTM	Class II	2005-03-09
K050292	Sharpoint Lukens Bone Wax	Surgical Specialties Corp	MTJ	Unclassified	2005-03-09
K050148	Mentor Aris Trans-Obturator Tape and Surgical Kit	Mentor	OTN	Class II	2005-03-09
K043478	Powdered Yellow Synthetic Vinyl Examination Gloves, Small, Medium, Large, X-Large	Shijaizhuang Brilliant Ocean Plastic Co., Ltd.	LYZ	Class I	2005-03-09
K042945	Aura CPAP System	Aeiomed, Inc.	BZD	Class II	2005-03-09
K042797	Wro 300 Water Purification System for Hemodialysis	Gambro Renal Products	FIP	Class II	2005-03-09
K042109	Diasys Integra II	Novacor France	DXN	Class II	2005-03-09
K042107	Tung Fu Airmate TENS, Vitality Mode, Tf-Dt001	Tung FU Electric Co., Ltd.	GZJ	Class II	2005-03-09
K042074	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2005-03-09
K050447	Performa Adult Hollow Fiber Membrane Oxygenator	Dideco S.p.A.	DTZ	Class II	2005-03-08
K050304	Fx Wire Advanced Measurement Guidewire	Conmedcorp	OCY	Class II	2005-03-08
K050111	Smarxt Bmr 1900 Closed Venous Reservoir Bag	LivaNova USA, Inc.	DTN	Class II	2005-03-08
K043585	Medline Surgical Gowns	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	2005-03-08
K043235	Dragon Heart i.v. Set	Dragon Heart Medical Devices Co., Ltd.	FPA	Class II	2005-03-08